Vaccination

Tuesday, March 03, 2015

First of all, we need to define some terms. Researchers do not use the phrase, "vaccine injury" -- that's a phrase from the anti-vaccination movement.

Let's say you choose to get yourself an influenza vaccine. Within hours or days of receiving the vaccine, you have an episode of ill-health (bear with me, here). The ill-health can be one of two things:

An Adverse Event: A new medical or physical adverse state, associated in time with the receipt of the vaccine. This state may or may not have anything to do with the receipt of the vaccine -- it just follows the receipt of the vaccine.

An Adverse Reaction: A new medical or physical adverse state(or more rarely, the worsening of a previous adverse state) that can be reliably said to be caused by receipt of the vaccine.

In the research literature, the phrase adverse events following immunization (AEFI) is used.

Most physicians and vaccine researchers would say that yes, serious or persistent adverse reactions to vaccines happen, but they are very, very rare. The United States has two formal, funded ways of tracking adverse events: The Vaccine Adverse Events Reporting System, or VAERS, and the Vaccine Safety Datalink (more on VSD in a later post).

How else can we estimate the risk posed by a particular vaccine? Well, the US also has the National Vaccine Injury Compensation Program (NVICP), established in 1986, which compensates individuals who may have been injured by vaccines. (A more complete description is available at History of Vaccines.) NVICP, from time to time, publishes statistical reports. Lately, they have taken to publishing a table of compensated injuries, sorted by vaccine, "National Vaccine Injury Compensation Program (VICP) Adjudication Categories by Vaccine for Claims Filed Calendar Year 2006 to Present". I decided to look at the rate of compensable awards per 1,00,000 doses distributed, for each vaccine in the talbe.

First I looked at those for which there was a concession [1]or court decision [2]. I sorted the vaccines from the highest percentage of awards to the lowest (you can click to enlarge.) The single-antigen rubella vaccine (which is no longer available in the US) has the highest rate of award at 2.37 per million doses, followed by the Diphtheria + Tetanus vaccine, at 1.53/million. The rate drops off precipitously thereafter. The first vaccine on the pediatric schedule to be listed is the MMR +Varicella, with 0.73 awards per million doses.

Then I looked at just the settlement [3] cases. This time, the single-antigen measles vaccine (which is no longer available in the US) had the highest rate of awards, but this may well be a function of small numbers. The first vaccine on the pediatric schedule to be listed is the DTaP, with 0.99 awards per million doses.

Finally, I looked at the total compensated cases. Again, the single-antigen measles vaccine (again no longer available in the US) was at the top. The first vaccine on the current pediatric schedule to be listed is the MMR +Varicella, with 1.45 awards per million doses.

What can we say about these tables? Bad things happen after vaccination -- to a very, very few people. Influenza vaccines are now, by an order of magnitude, the most-often claimed, and compensated, vaccine.

[1} Concession: HHS concludes that a petition should be compensated based on a thorough review and analysis of the evidence, including medical records and the scientific and medical literature. The HHS review concludes that the petitioner is entitled to compensation, including a determination either that it is more likely than not that the vaccine caused the injury or the evidence supports fulfillment of the criteria of the Vaccine Injury Table. The Court also determines that the petition should be compensated.

[2] Court Decision: A special master or the court, within the United States Court of Federal Claims, issues a legal decision after weighing the evidence presented by both sides. HHS abides by the ultimate Court decision even if it maintains its position that the petitioner was not entitled to compensation (e.g., that the injury was not caused by the vaccine).

For injury claims, compensable court decisions are based in part on one of the following determinations by the court:

The evidence is legally sufficient to show that the vaccine more likely than not caused (or significantly aggravated) the injury; or

The injury is listed on, and meets all of the requirements of, the Vaccine Injury Table, and HHS has not proven that a factor unrelated to the vaccine more likely than not caused or significantly aggravated the injury. An injury listed on the Table and meeting all Table requirements is given the legal presumption of causation. It should be noted that conditions are placed on the Table for both scientific and policy reasons.

[3] Settlement: The petition is resolved via a negotiated settlement between the parties. This settlement is not an admission by the United States or the Secretary of Health and Human Services that the vaccine caused the petitioner’s alleged injuries, and, in settled cases, the Court does not determine that the vaccine caused the injury. A settlement therefore cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury. Claims may be resolved by settlement for many reasons, including consideration of prior court decisions; a recognition by both parties that there is a risk of loss in proceeding to a decision by the Court making the certainty of settlement more desirable; a desire by both parties to minimize the time and expense associated with litigating a case to conclusion; and a desire by both parties to resolve a case quickly and efficiently.

Tuesday, September 30, 2014

In a March 31 interview with Al-Monitor, Nancy Lindborg, assistant administrator for the Bureau for Democracy, Conflict and Humanitarian Assistance at the US Agency for International Development (USAID), said that the World Health Organization (WHO) and UNICEF have managed to make progress against an outbreak of polio in Syria, but added, “What we are seeing with the coming of warm weather is the possibility of measles outbreaks.”

The Syrian Arab Red Crescent Idleb branch sent a humanitarian aid convoy consisting of 25 trucks loaded with food parcels and hygiene kits and other relief materials to Northern Rural Idleb (al-Qah – Atmah) in coordination with all parties on the ground.

The convoy consisted of food parcels, hygiene kits in addition to water purification materials and children medicines with a support from the UNICEF, UNHCR and WFP. The distribution of these material continues in eleven camps accommodate around 2552 families with the supervising of SARC Idleb branch volunteers.

The "children medicines" included measles vaccines.

On September 16, 2014, tragedy struck. A number of children died immediately following vaccination. There was widespread speculation, but the cause turned out to be human error.

A WHO assessment of the cause of the death of 15 children in rural Idleb, northern Syria has concluded that the most likely cause of the event was the incorrect use of a drug called Atracurium as a diluent for Measles/Rubella vaccine.

There is no evidence that the Measles/Rubella vaccine itself or its correct diluent were the cause of this tragic event.

Measles vaccine has to be reconstituted with a diluent prior to use. All evidence available to the assessment team indicates that the incorrect use of Atracurium as a diluent was the cause of the deaths. Atracurium is a muscle relaxant and is used mainly as part of the anaesthetic procedure for surgery. The Atracurium ampoules were incorrectly added to vaccination packs prepared in one District Vaccine Distribution Centre in Idleb Governorate and distributed to four vaccination teams on the second day of the measles campaign.

Anyone in the developed world who points to this tragedy as evidence that immunization is "dangerous" should be treated with the utmost contempt.

"[Schneider’s] ad has unintentionally been used as a platform for discussion unrelated to the products and services we provide," he said. "With that, we are working to remove the ad from our rotation at this time."

The ad was created by the advertising agency DDBChicago. Evidently the creative team was unaware, or didn't care, about Schneider's anti-public-health actism.

There's a Facebook page called Chow Babe (created to mock The Food Babe). The moderators created the following ad to counter Schneider's appearance in "Steve's Kid -Richmeister" ad, asking people to "Please join us in stemming the modern anti-technology tide!"

The criticism that the study discarded data from African American subjects just doesn’t hold water. No data was discarded. For the subjects who were linked to birth certificates, the researchers performed additional analyses. In this light, I see a careful observational study that assessed the role of potential confounders.

The biggest weakness that I see for this study is that the researchers could not compare subjects who were vaccinated for MMR to those who were not vaccinated at all. The authors wrote that they “lacked an unvaccinated comparison group.” The truth is that the vast majority of kids are vaccinated. Consequently, this study compared the distribution of vaccination ages for case and control children to see if the timing impacted the risk of autism. It didn’t.

The full data set has been sliced and diced into a small, biased sample.

Low birth weight is an uncontrolled, confounding variable

Please read the whole post. I have elided several paragraphs

Thanks to the tiny sample and the uncontrolled confounding variable, Hooker’s results are both imprecise and biased. Consequently, my personal opinion is that Hooker’s results have no scientific value at all.

I’m Jim Frost and I came to Minitab with a background in a wide variety of academic research. My role was the “data/stat guy” on research projects that ranged from osteoporosis prevention to quantitative studies of online user behavior. Essentially, my job was to design the appropriate research conditions, accurately generate a vast sea of measurements, and then pull out patterns and meanings from it.

Now at Minitab, I am a technical writer who helps people use our software to gain insights from their own data, whether they’re working in quality improvement, academic research, or another field entirely. I’ll be writing about various experiences and practical tidbits that I’ve learned along the way that may help you in your own research endeavors.

The two papers under discussion

1. DeStefano, Frank, Tanya Karapurkar Bhasin, William W. Thompson, Marshalyn Yeargin-Allsopp, and Coleen Boyle, Age at First Measles-Mumps-Rubella Vaccination in Children with Autism and School-Matched Control Subjects: A Population-Based Study in Metropolitan Atlanta, Pediatrics, 2004;113;259

There is no plausible way that [something injected after birth could cause autism] could happen. It makes absolutely no sense with what we know to be true about autism. Even though to the layperson it sounds convincing that foreign DNA injected into a developing child could somehow go to the brain and cause autism, there is no credible way that that could actually be the case. Not with the overwhelming evidence that autism begins before birth. This is yet another in a series of plausible sounding untruths about vaccines that are so convincing to the average, intelligent parent just trying to learn more....

I do not know why the authors of this article published the conclusions that they did, or why they chose to publish their work in such a questionable publication. In no way do I want to impugn their characters or call into question what are probably deeply held beliefs on their parts. However, deeply held beliefs do not make for rigorous scientific inquiry. And pro-life parents seeking to do the best by their children and by their culture deserve better than to have a plausible sounding lie masquerading as truth.

Autism is usually diagnosed between ages 2 and 4; so, unless the power of these evil tainted vaccines to contaminate the DNA of our precious children can also travel back in time, it’s hard to take correlations between these change points and vaccine introduction as anything more than spurious pseudo-correlations. It would be so hilarious if the consequences of such fear mongering weren’t so dire, although even then it’s still useful as a cautionary tale worthy of extreme mockery of how not to do linear regression and inflection point “hockey stick” analysis.

Deisher commits the cardinal sin of scientific research: she confuses correlation with causation. There is even some question whether even the correlation she posits actually exists.

This is bad science....

But if we are going to hesitate over any vaccine, let it be for medically and theologically sound reasons. Dr. Deisher has not provided either. Her study displays a conflict of interest; it banks on an emotional response to an ethical question; and most damningly, it relies on heavily flawed science. Catholics should keep their eyes open for other scientists whose research is sound.

If someone were to ask me to critically appraise the scientific merits of a study arguing that birth control usage caused earthquakes by changing the mating behaviors of fish, I might have had an easier time than I did with Dr. Theresa Deisher’s widely shared study. That may be over the top, but it is kind of true. In such a scenario, I would have been able to say to myself, like most other people in the scientific blogosphere are doing with the Deisher study, “This is just too absurd, too poorly done to waste any more time refuting it!” But, I can’t do that because you, my brothers and sisters in Christ, deserve to know how badly you are being deceived by a study that is so abominable, it would be an insult to bad science to call it bad science.

[in-depth analysis of Deisher's statistical failings]

Stay tuned for criticism of the biological plausibility and synthesis of Deisher’s conclusions…

There are some things I want to make perfectly clear: I chose to operate under many of Deisher’s assumptions that I knew weren’t particularly or necessarily valid because I didn’t need to exit that paradigm to point out the flaws in the rationale. However, there are more reasons to think Deisher’s analysis is flawed from the outset and I’d like to address just a few.

We’re finally back to Deisher, who from her paper does not appear to appreciate these and similar points. I find the paper poor in conception, argument, and quality, and regard her main contention as unproved (which is logically consistent with it is still possibly true).

Vaccines and Autism: This is Starting to Get Really Weird by Joseph Moore at Yard Sale of the Mind (September 19, 2013)--Evidently, feelings about Deisher and her paper, pro and con, are running quite high in a segment of the blogosphere I can best describe as Roman Catholics doing science. Mr. Moore describes.

Deisher’s study is incredibly, incredibly thin in the realm of biological plausibility. This is surprising (or not) because she is making some novel, extraordinary claims. Yes, she has a nice bibliography salad, but the studies she cites do not directly, or even indirectly at times, support her central hypothesis that DNA from fetal cell lines is a direct environmental cause for increasing autistic disorder (AD) diagnoses. Further, even her unpublished research that has been cited in newsletters and pro-life media means very little in terms of the hypothesis.

The takeaway from Deisher's study -- at least as it's being expressed throughout the Catholic blogosphere -- is that autism must be cured (if not eliminated), and that, in fact, autism can be avoided (if not eliminated) if the rubella vaccine, which was derived from the stem cell line of an aborted baby more than fifty years ago, is no longer used. This assumes that autism is a Very Bad Thing, devoutly to be un-wished for, and that it's worth risking the deaths of countless babies (other people's babies; it always is) in utero to avoid it. This is not just theologically faulty; it's morally faulty.

[Deisher] did however, apply for an NIH grant to perform this research. The petitioners claim that the controversial nature of the study resulted in it not being funded. The referee reports, however, were clear that the planned study was weak and Ms. Deisher’s skills were not strong in epidemiology and statistics (among other weak points).

Although petitioners make assertions to the contrary, the evidentiary record before the undersigned contains a withering assessment of Dr. Deisher’s ability to competently lead the proposed study. Petitioners here seek extraordinary relief, and the undersigned is reluctant to substitute her scientific judgment for that of the NIH reviewers—a panel of Dr. Deisher’s peers—who have found her proposed study to be critically deficient. In the undersigned’s view, the NIH reviewers’ comments merit weighted consideration.

....[Deisher's argument] doesn’t make a lot of sense, strictly from the standpoint of a temporal correlation. After all, these cell lines were derived over 40 years ago. If there was a correlation between DNA from these cells in vaccines and autism (or any other of the problems blamed on vaccines), wouldn’t it have started decades before the early 1990s?

.... why this doesn’t happen frequently from the many viruses humans are exposed to each and every day or after a blood transfusion. Or what about childbirth? There is almost always some mixing of fetal blood with the mother’s blood upon childbirth, meaning that the mother is exposed to fetal DNA from white blood cells and monocytes in the fetal blood. Why is it that mothers don’t all get anti-DNA autoimmune diseases after childbirth?

Note: It is true that Deisher spent from 1980 to 1990 as a student at Stanford University, first as an undergraduate and then as a PhD candidate in the Department of Molecular and Cellular Physiology. However, she has not been associated in any way with Stanford for 24 years, so any publication referring to her as a "Stanford scientist" should be viewed with deep suspicion.

Previously, I went over the broader issues around Brian Hooker's recent paper, mentioning Hooker and Wakefield's accusations against Marshalyn Yeargin-Allsopp, MD in passing. Now, I want to put those accusations right up front.

Hooker's research was funded by the anti-vaccine organization, Focus Autism, Inc. In the press release on Hooker's paper, the organization made the following claims:

According to Hooker, the CDC whistleblower informant -- who wishes to remain anonymous -- guided him to evidence that a statistically significant relationship between the age the MMR vaccine was first given and autism incidence in African-American boys was hidden by CDC researchers.

Dr. Hooker stated "The CDC knew about the relationship between the age of first MMR vaccine and autism incidence in African-American boys as early as 2003, but chose to cover it up." The whistleblower confirmed this. When asked if there could be any scientific basis for excluding children born outside of Georgia, Hooker responded, "I know of none, and none has been provided by the authors of the DeStefano study." He added, "The exclusion is reminiscent of tactics historically used to deprive African-Americans of the vote by requiring valid birth certificates."

In his two videos (one, two) promoting the Hooker paper, Andrew Wakefield compared the alleged coverup (to which Dr. Yeargin-Allsopp would have had to been a party) to the infamous Tuskegee syphilis experiments, and in a later segment, compared Dr. Yeargin-Allsopp and her CDC colleagues to some of the most heinous figures in history

"You see, vile as the crimes of Stalin, Pol Pot and Hitler were, these men were not hypocrites.... These men were not entrusted with the welfare of their victims. Their mottos did not include the words, 'To save lives and protect.' They were not running a mandatory program disguised as caring.

"How many children? How many went to the wall in that decade of silence? How many Presidents, Mr. Obama?"

So. According to Hooker, Wakefield, and Focus Autism, a respected senior African-American physician-researcher is a race traitor and a mass murderer.

--------edited to add: In the United States and elsewhere, there are complex issues around race, culture, and socio-economic status and the early, accurate identification of autistic individuals, and the provision of adequate supports and education for those individuals and their families.

------

edited to add: Evidently I was unclear, or readers need more clarity. Brian Hooker claims he was put on to the CDC-MMR "coverup" by a CDC employee, William W. Thompson, PhD/

The paper was a case-control study. The gist of the paper is that vaccination with MMR was similar for the 624 autistic children and the 1824 non-autistic children. The paper was one more piece in the wall that reads: "vaccination does not cause autism."

The short version: Hooker is not an unbiased scientist; he's a man with an agenda: to prove that somehow, someway that vaccines cause autism; the CDC knew this as early as 2000; and that people at CDC have concealed data with malicious intent.

On August 8, 2014, Hooker published his latest paper, "Measles-mumps-rubella vaccination timing and autism among young African American boys: A reanalysis of CDC data". This paper re-analyzed the dataset (designed as for a case-control study) used in deStefano paper, using a cohort methodology and a different and less subtle statistical test. This is technical stuff, but it's critical to the validity of Hooker's findings. What Hooker claims to have found: " a 3.36-fold increased risk for autism in African-American males who received MMR vaccination before the age of 36 months"

The anti-vaccine front group, Focus Autism, published a press release on the Hooker paper, including the following claims:

Friday, August 08, 2014

The cleverly-named National Vaccine Information Center (NVIC) appears to be an official, authoritative organization on vaccine safety. In reality, NVIC is a nonprofit whose only purpose is to spread fear, uncertainty and doubt (FUD) about the safety and efficacy of all vaccines.

NVIC uses websites and other social media to spread misinformation. The organization's Facebook page has received 92,700 likes. NVIC's twitter handle @vaxcalc has issued over 30,000 tweets, each spreading untruths and FUD about vaccines.

NVIC is completely indifferent to the truth of anything they post, as long as it serves their bias. A perfect example occurred this morning on the NVIC facebook page.

When NVIC found an article claiming that the flu vaccine causes MRSA, they gleefully shared it.

The post was silently removed from NVIC's Facebook feed, after it had been shared twice and received 10 likes.

What NVIC did not do was to spend so much as a moment to fact-check the post.

Then, what NVIC did not do was to acknowledge that they posted an article from a hoax site as though it were true. They did not apologize to their followers for posting such a misleading article.

This is just one example of how NVIC misleads their followers. There are many more.

NVIC's Facebook page is evidently managed in part by Paul F. Arthur, who is NVIC's Director of Operations. He is also the husband of Barbara Loe Fisher, NVIC's President and co-Founder.

As of 11 am PDT, the parody post was still up at Mr. Arthur's Facebook page.

Updated to add: In July, WIT published a shocking, hurtful article alleging that the vast majority of convicted murderers have Asperger's; the American Journal of Medicine published a post exposing the hoax as did Elsevier Connect

Thursday, May 08, 2014

PRATT:A point refuted a thousand times, commonly abbreviated as PRATT, refers to a point or argument that has literally been refuted so many times that it is not worth bothering with. It is a common phrase on internet forums - as debates have a tendency to go in circles. Once people have refuted a point the first thousand times, it's hard for them to muster the motivation to do it again.